Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

The Common Rule provides basic information about the required elements of informed consent for all research with human subjects. These elements include not only consent documentation but also consent alteration and waivers of consent. The Advance Notice of Proposed Rulemaking (ANPRM; 76 Fed. Reg. 44,512-44,531) contains an extensive list of suggested changes to these requirements for informed consent, many of which respond to prior criticisms regarding the length, legibility, and content relevance of consent forms; the time institutional review boards (IRBs) take to edit and revise forms; ambiguity and inflexibility in IRB waivers for informed consent; and adequacy in addressing consent related to re-use or additional analysis of existing data and biospecimens (Fisher et al., 2013, p. 9). The importance of informed consent in the protection of human subjects is without dispute. It is one of the “bedrock principles of ethical research with human participants” (National Research Council, 2003; Nuremberg Military Tribunals, 1949).

The committee recognizes that respecting persons, and respect for autonomy and voluntariness, requires that informed consent be obtained from people asked to participate in research, regardless of the level of risks of participation, unless the research meets certain criteria that render consent unwarranted. But changes in the regulations and additional guidance are necessary if the process of informed consent is to be meaningful. Over time, the process has in many cases devolved to focus on the creation of a complicated legal document rather than to deliver the purpose of informed consent: informing potential subjects that research is taking place and

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

providing them with the actual information that they require to make an informed decision about whether to participate.

In the decades following the promulgation of the regulations for human-subjects research, there has been considerable confusion about the requirements for informed consent in the context of the social and behavioral sciences and about how much flexibility is permissible in the process of obtaining informed consent (Burgess, 2007; Capron, 1982; Elms, 1982; Macklin, 1982; National Research Council, 2003). This uncertainty is even greater with the expanding use of large-scale digital databases where the focus cannot be on the transaction of consent alone but also on the ethical, legal, and other legitimate claims and ground upon which they rest. The importance of supporting an informed consent process that is meaningful, ongoing, and flexible when applied to studies that range from nonsensitive, anonymous surveys to those that might pose significant informational or psychological risk or involve populations with questionable consent capacity cannot be overstated. IRBs struggle to understand how to apply informed consent regulations to many of these studies. As the ANPRM notes, current regulations on informed consent are confusing and inflexible and may require inclusion of inappropriate content. Moreover, IRBs may read the regulatory requirements in a way that limits what flexibility is now permissible.

The 2003 National Research Council (NRC) report, Protecting Participants and Facilitating Social and Behavioral Sciences Research, provided an expansive review of issues in the informed consent process for IRBs reviewing social and behavioral research proposals and provided yet-to-be adopted guidance for helping IRBs and researchers apply the Common Rule provisions in the process of obtaining informed consent. The ANPRM addresses some of those recommendations, but many of its solutions do not fit well for the social and behavioral sciences, and there are wide gaps in applicable guidance. In this chapter, the committee updates and expands upon the recommendations of the 2003 NRC report. We discuss the importance of flexibility in the informed consent process, propose that issues of institutional liability be separated from requirements for informed consent, and provide suggestions for informed consent relating to data collection.

The purpose of informed consent is to inform potential participants about the study’s purpose, harms, risks, benefits, and other information that allows the person to make an informed decision about participation. Even a no-risk study requires consideration of informed consent out of respect for personhood and the right to self-determination. Consent may legitimately take many forms and should be tailored to the requisites of the study and the characteristics and needs of the study population. As many have said before, consent is a process, not a document (Oakes, 2002). Thus, this committee agrees with the Secretary’s Advisory Committee on Human

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Research Protections and others that the ANPRM continues to have regulatory focus on the form rather than the process (Secretary’s Advisory Committee on Human Research Protections, 2011). While the elements of informed consent listed in current regulations1 are important to ensuring the informed, rational, and voluntary nature of consent, they may not all be necessary in the context of a given study, and a documented form may not be required at all.

Flexibility and Inclusion of Protocol-Relevant Elements of Informed Consent Is Essential for Social and Behavioral Research

The committee supports the ANPRM’s efforts to shorten the length of consent forms. We also agree with the ANPRM that the length and assumed reading levels of current forms increase the likelihood that participants do not fully comprehend what they are consenting to (76 Fed. Reg. 44522). Given the diversity of participants with respect to cultural, educational, and mental health and developmental levels, a standard informed consent form seems unlikely to improve participant comprehension of consent in practice. Social and behavioral research involves many research contexts and many different populations—and therefore many different specific requirements for informed consent (Sieber et al., 2002).

The focus of the ANPRM was primarily aimed at changes that would (1) improve comprehension in informed consent and (2) increase efficiency in the research process. While the committee agrees that both aims are important, we believe that changes to the regulations and accompanying guidance should more explicitly target the flexibility afforded to IRBs, while still maintaining appropriate subject protections and accountability in the informed consent process. In developing flexible consent procedures fitted to the consent needs of the participant population, the U.S. Department of Health and Human Services (HHS) can draw on a framework that conceptualizes participant respect and protections in terms of the goodness of fit among the current cognitive and health status of the participant, the education and experience of the participant, the cultural context required to understand the nature of the specific research protocol, and participants’ rights (Fisher and Goodman, 2009; Flory and Emanuel, 2004; Kiguba et al., 2012). The goodness-of-fit framework calls for scientists to construct informed consent procedures guided by (1) the moral principles of respect, care, and justice; (2) responsiveness to the abilities, values, and concerns of

_________________

1For a summary list of elements of informed consent, see National Research Council (2003, p. 82, Box 4-1).

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

participants and their surrogates; and (3) awareness of the scientists’ own competencies and obligations (Fisher, 2002, 2003a, 2003b; Masty and Fisher, 2008). This framework provides a better focus than do either current regulations or the ANPRM on the context of research and the actual needs of potential participants. Instead of simply checking off the required elements of informed consent, researchers and IRBs would assess which elements are required and how best to convey that information to participants.

Emphasizing Process over Documentation

The regulations should eliminate language suggesting that written informed consent disclosures and written documentation that consent has been obtained are the preferred norm. Rather, language should stress that informed consent is a process of communication that provides investigators with the flexibility to tailor the content and modality of disclosures to the specific research context and the information needs of prospective participants, including the opportunity for a prospective participant to ask questions to enhance understanding. Informed consent should be viewed not as a point in the research but rather as a continuing iterative process.

While the committee supports the ANPRM goal of streamlining the documentation requirements for informed consent, we do not believe that goal is sufficient. Regulatory changes should concentrate instead on increasing flexibility in the informed consent process. That flexibility can enhance the informed, rational, and voluntary requirements for consent, not simply its expediency. The aim of regulatory reform should be to give IRBs the freedom to be flexible without diminishing human subjects protection, while being supportive of researchers.

Flexibility in Timing of Approval of Informed Consent Processes

Many IRBs require social and behavioral researchers to finalize their informed consent process before they start research, as is the norm with biomedical research. Before the research can commence, the IRB requires approval of an informed consent form. But some types of social and behavioral research, especially ethnographic research, involve research where the researcher cannot predict how the research will evolve and may not even be able to identify all participants until some data have been collected (Lederman, 2006; Murphy and Dingwall, 2007; Simpson, 2011; Thorne, 1980; Yanow and Schwartz-Shea, 2008). If the ANPRM’s proposals for new categories of research are adopted, much of this research may fall into the new “excused” category. In that case, the researcher should apply good professional judgment to tailor informed consent to the situation at hand.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

However, where more than minimal risks are involved, or where the research may be no greater than minimal risk but requires additional protections to maximize benefits and minimize harms, IRBs and researchers should have the flexibility to work together to allow the informed consent disclosures’ timing to be appropriately fitted to participant characteristics and the research context. The researcher should not be required to come back to the IRB for approval of every revision in the informed consent process. Instead, alternative possibilities should be discussed and approved at the outset, with the researcher selecting among those approved alternatives as the reality of the research evolves. For situations where IRB action is required but it can be anticipated that quick approval will be necessary, prior arrangements should be made between the researcher and the IRB that allow for this process of discussion and approval of alternatives. An example of this was provided by Silver in describing how to work with IRBs in facilitating the review of trauma research during disasters (National Research Council, 2013).

Restructuring the Concept of “Waiver of Consent”

The current regulations already offer a great deal of opportunity for flexibility (45 C.F.R. § 46.116(c)). As cited in the 2003 NRC report, many or most IRBs do not use this flexibility for a variety of reasons (Puglisi, 2001). While the regulations allow for alteration as well as waiver, some IRBs ignore opportunities for appropriate alteration and instead debate waivers of consent or waivers of consent documentation. In light of the flexibility proposed by the ANPRM and recommended in this report, the language of 45 C.F.R. § 46.116(d) needs to be reconsidered. As the ANPRM suggests, the regulations might go further in considering a restructuring of the process of “waiving” requirements.

For example, the requirement to demonstrate that the research cannot “practicably” be carried out without the waiver or alteration places an undue burden on IRBs to include consent information that may be irrelevant to adequate human subjects protections simply because a longer, more burdensome, and possibly less comprehensible form could conceivably be implemented by the researchers. Similar problems may arise in asking investigators and IRBs to actively demonstrate that waiver of specific elements of consent “will not adversely affect rights and welfare of the participant,” as well as to document that the research could not “practicably” be done without the waiver, a word that is confusing and variously interpreted by IRBs (Secretary’s Advisory Committee on Human Research Protections, 2011). Requiring IRBs to affirm this statement about what is “practicable” makes many IRBs cautious about granting such allowances because they feel that they are assuming a risk in granting the waiver, even when that risk

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

is benign or nonexistent. In addition, IRBs may face institutional pressures not to take on any such risk (Klitzman, 2013).

The current language thus results in informed consent forms or procedures that are long, overly complex, and confusing (Albala et al., 2010; Klitzman, 2013; Stunkel et al., 2010). For example, as others have pointed out (Secretary’s Advisory Committee on Human Research Protections, 2011), the required element to discuss alternative procedures with a prospective participant is typically not applicable in nonclinical studies and should not be an element that needs active defense to remove it from the consent process or form. Fitting the consent disclosures to the specific research procedures, population, and context should not cause IRBs any hand wringing but rather should simply be one of an equally valid set of alternatives in the informed consent process.

The 2003 NRC report’s chapter, Enhancing Informed Consent, addressed the issue of what elements should be required in informed consent; that report’s Recommendation 4.5 states: “The Office for Human Research Protections should develop detailed guidance for IRBs and researchers, including specific examples, on when it is acceptable to omit elements of informed consent in social, behavioral, and economic sciences research” (National Research Council, 2003, p. 108). This process itself is also problematic, in that IRBs are given a “full basket” of requirements for the informed consent process and form; they then have to document and defend any decisions to allow for removal of any requirement by “granting a waiver or alteration.” If the process were instead one where elements were listed as considerations, rather than required as standard elements, the IRB could start with an “empty basket” and add in those elements that were necessary, appropriate, and warranted for informed consent in the research context. This solution does not address the problem of reviewers who may be overly risk-averse, but it is a step in the right direction: reforming the approach IRBs should take and allowing more flexibility.

OHRP guidance could also advise IRBs that shorter informed consent processes communicate better to participants than do overloaded processes (Martin and Marker, 2007). In addition, OHRP could provide IRBs with assurance that they do not bear increased risk by requiring only the elements warranted by the research.

Critical criteria to consider for which elements of consent information to include are the following: (1) What disclosures are essential to ensure that members of the population to be recruited can reasonably determine whether or not they would find participation in the specified study to be a desirable or undesirable experience? (2) What disclosures are essential to ensure that members of the population to be recruited are aware of the extent and limits of human subjects protections most relevant to the personal consequences of their participation in the specified study? For each

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

research proposal, answers to these questions should be calibrated to both the probability and magnitude of harm posed by the proposed research procedures, the adequacy of data protections, and the characteristics of the population or research setting that might compromise the informed and voluntary nature of consent.

Relatively simple, low-risk studies may convey the information essential for informed consent in a couple of sentences of text at the top of the survey or at the start of a brief telephone interview. For example, a survey study on cigarette smoking behaviors and attitudes involving a community sample of healthy and cognitively competent adults may only require a few sentences describing the purpose and nature of the study, confidentiality protections, and investigator contact information. If the study involves no or low risk, a superficial statement regarding research risks and benefits would not be required.

For other populations and in certain contexts, additional elements may also be appropriate. In some contexts, for example, it may be important to include a statement that deciding not to participate results in no penalty or other consequence. In many studies, it may be important to discuss confidentiality or data security and to inform prospective subjects about who will see their information or who will know they participated. For instance, a similar smoking survey that is conducted in a hospital setting with patients admitted for treatment of lung cancer would require additional consent disclosure to ensure that patients understand that refusal to participate will not jeopardize their treatment. Disclosure would also be needed to inform patients about whether or not their survey responses will be included in their health records.

Flexibility in Form and Documentation of Consent

The ANPRM sought to clarify regulatory requirements and remove barriers to more flexible and diverse consent processes and documentation. The committee agrees with these aims and offers here some specific suggestions for increased flexibility.

The current regulations put too much emphasis on documentation. In many cases, a written signature indicating participant consent should not be necessary. Moreover, in some situations, documentation might actually increase risk (Cardon, 1984; Elliott, 2002) or bias samples (Singer, 1978; Trice, 1987). Many researchers, and even IRBs, are not aware that many research projects have a valid option of gathering verbal consent from individuals without having them sign a written consent form. Thus, researchers and IRBs may not be comfortable permitting the elimination or alteration of the consent form. However, providing potential subjects with a one- to two-page “fact sheet,” writing a letter of introduction to the study that is

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

attached to a questionnaire, and/or gathering verbal consent to participate in a study are appropriate forms of informed consent for many research studies. Similarly, some forms of “implied consent” should be expressly permitted by the regulations. When someone reads a letter outlining the elements of consent, then proceeds to complete a questionnaire and return it, there is neither “written consent” nor “oral consent,” but the subject has still consented by continuing with the research. This should be a valid and clear option not necessitating any action on the part of the IRB to “grant a waiver,” which is how many IRBs currently interpret the regulations. This confusion may be exacerbated by current guidance, which may confound the form of the consent with the requirement of the necessary elements (U.S. Department of Health and Human Services, 2011).

The informed consent should be tailored to the context of the research and the needs of the potential participants (Burgess, 2007). In some cases, the consent disclosure information may be better communicated through nonwritten means. A conversation may be appropriate, conveying what is needed to ensure a participant’s informed consent. Sometimes emails or notices may be all or part of the informed consent. For example, an anonymous, brief, one-time survey might warrant the researchers simply telling potential participants that they are researchers, their affiliation, and what participation entails, with no written information conveyed nor any documentation required. In more complex research, multiple formats such as visual aids and video may improve communication and understanding (Moseley et al., 2006). In other studies, the subjects may need to have some written information to take with them or to comprehend what is being asked of them (Cameron et al., 2011).

The committee believes that 45 C.F.R. § 46.117 should be revised to encourage oral consent in appropriate situations. Oral consent may greatly enhance communication in many more contexts than those in which it is currently permitted (Dawson and Kass, 2005). One option would be to extend the oral plus brief written statement recommended by the Office for Human Research Protections (OHRP) for research involving participants who do not speak English, in order to provide full informed consent in many contexts.2 This may provide the most ethically appropriate approach to ensuring clear understanding and voluntary participation decisions across a broad range of populations. IRBs should be encouraged to apply the flexibility afforded by this policy for research involving individuals (a) with limited reading ability, (b) for whom English is a second language, (c) who have minor cognitive deficits, or (d) who live in war-torn

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

or other dangerous environments in which a document of consent or other records of participation may jeopardize physical safety. Other contexts in which oral consent plus a brief written statement may be appropriate include (1) research settings (e.g., hospitals, business organizations) that promote a deference to authority that is potentially coercive, (2) research settings where a written document may jeopardize participant safety, or (3) settings where research is conducted solely through telephone contact or via mail or Internet. This approach of oral consent plus short written form is also appropriate for assent procedures involving children and adolescents (Fisher et al., 2013, p. 10).

Recommendation 4.1: HHS should eliminate regulatory language that suggests certain formats or elements are a default in all situations and focus instead on tailoring consent to be appropriate to the situation and population. This revision should include eliminating ambiguous language currently in 45 C.F.R § 46.116(d) that has caused IRBs to include consent information that may be irrelevant to adequate human subjects protection.

Guidance Recommended: OHRP guidance should be provided to help IRBs and investigators in emphasizing process over documentation and encouraging flexibility in consent methods, including processes that enable consent to evolve to ensure the quality of the informed consent process.

OHRP should also provide guidance on how to determine what elements to include in consent information, which should be calibrated to both the probability and magnitude of harm posed by research procedures, the adequacy of data protections, and characteristics of the population or research setting that might compromise the informed and voluntary nature of consent.

Recommendation 4.2: HHS should eliminate language in the regulations suggesting that written informed consent disclosures and written documentation that consent has been obtained are the preferred norm and include language permitting informed consent by nonwritten means when appropriate, without requiring action by the IRB to grant a waiver of documentation.

Distinguishing Participant Risk from the Risk of Institutional Liability

The ANPRM includes changes to the Common Rule intended to separate a research institution’s concerns for limiting institutional liabilities unrelated to human-subjects research protections from informed consent

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

to being a participant (or subject) in the research. The committee fully supports the position stated by the SRCD Task Force on this differentiation of participant risk and institutional liability (Fisher et al., 2013, pp. 9-10), although the committee would widen the focus of the Task Force on children and adolescents to include any individual unfamiliar with the research process:

We [the SRCD Task Force] agree with ANPRM recommendations to improve consent forms in ways that enhance prospective participant (and guardian) understanding of their research rights and procedures. In particular we appreciate the ANRPM’s willingness to address the problem of over-inclusion of institutional-liability clauses in informed consent. In many instances statements regarding an institution’s lack of legal liability refers to risks outside of the research procedures themselves (e.g., falling while walking down a hall) and thus do not belong in the informed consent [form].[3] In addition, liability waivers included in an informed consent document clearly violate the regulatory language in § 46.116, which states that no informed consent “may include any exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject’s legal rights or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.” This is particularly relevant to assent procedures for children and adolescents[4] who may interpret such language as a prohibition against alerting adults to harms incurred during research participation. We strongly recommend that (a) institutional liability statements be removed from informed consent documents for research participation and (b) institutions that wish to notify prospective participants or their guardians about limits to the institution’s legal liability do so in a separate document. (Fisher et al., 2013, pp. 9-10)

In support of this position, the committee makes the following recommendation in favor of removing institutional liability statements from informed consent forms and presenting them to prospective participants (or their guardians) in a separate document.

Recommendation 4.3: HHS should revise regulations to require that statements relating only to institutional or sponsor liability be clearly separated from the informed consent information directly related to the research participation.

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3The committee adds that inclusion of such statements limiting institutional liability may also lead to bias in recruitment in some social science research. See, for example, Trice and Ogden (1986).

4The committee would broaden this reference to include not only “children and adolescents” but also all individuals who, due to lack of education or experience, are unfamiliar with the research process. See Fisher and Wallace (2000) and Dawson and Kass (2005).

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

As Chapter 3 notes in the section, “Avoiding Overestimation and Underestimation of Harm,” IRBs without experience with social and behavioral research have a tendency, because of concern about adherence to regulations, to inflate potential risks in such studies without grounding their estimations in established scientific or professional knowledge. For their part, researchers may sometimes inflate potential scientific, social, or direct participant benefits. Both of these tendencies are understandable, but efforts are needed to ensure that the attribution of risks and benefits to proposed research are appropriate, accurate, reasonable, and evidence-based when possible.

In its response to the ANPRM, the SRCD Task Force complained of the tendency of IRBs to require statements on risks of stress or discomfort to participants, without scientific evidence for such harms:

For minimal risk research, too often in the absence of empirical or clinical evidence IRBs require investigators to include informed consent statements of “stress” or “discomfort” as a research risk when the probability and magnitude of such a risk is small or non-existent. Such statements can be deceptive and threaten scientific validity by unduly creating participant expectations of distress or harm. (Fisher et al., 2013, p. 9)

Although the committee would describe such statements as “misleading or inaccurate” rather than “deceptive,” we agree with the Task Force’s concern about unduly alarming participants without evidence for harm. More generally, descriptions of research risks and potential benefits should not include low-magnitude/low-probability risks and benefits. Doing so may misinform prospective participants, which is contrary to the legitimate goals of informed consent. Rather, consent disclosures should focus on those risks and benefits of reasonable probability that an individual would need to know to make an informed, rational, and voluntary decision to participate.

Guidance Recommended: OHRP guidance should clarify for IRBs that informed consent does not include risks and benefits low in magnitude and low in probability. Description of potential research risks and benefits should be limited to those that might reasonably occur and those risks that would cause substantive harm if they occurred.

Waivers and Research Involving Adolescents

Any proposed changes to the Common Rule sections on informed consent have particular relevance to research involving children and adolescents because Subpart D (Additional Protections for Children Involved as

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Subjects in Research), § 46.408, refers investigators and IRBs to Common Rule § 46.116 for information that must be considered when developing guardian permission and child assent procedures. Of particular concern for pediatric and developmental scientists conducting social and behavioral research are the significant barriers to the waiver of guardian permission that permeate IRB evaluations of requests for waiver of guardian permission for adolescent health research. For research involving no more than minimal risk, guardian permission can be waived under the current regulations (45 C.F.R. § 46.116). However, there has been widespread inconsistency in IRB application of these regulations to protocols surveying smoking behavior, alcohol and drug use, sexual behaviors, and other health-related attitudes and behaviors involving adolescents. One reason for this inconsistency is the lack of age-indexed guidance on evaluating the minimal risk criteria (Fisher et al., 2007; National Human Research Protections Advisory Committee, 2001; Secretary’s Advisory Committee on Human Research Protections, 2005), a topic this report addresses in greater detail in Chapter 3. Another barrier is failure of IRBs to consider the large body of empirical data summarized by the Institute of Medicine (2004) and the Society for Adolescent Medicine (Santelli et al., 2003) demonstrating that, starting at 14 years of age, adolescents’ understanding of the nature of medical and mental health treatment and research and rights-related concepts, such as confidentiality and voluntary assent or dissent, are similar to the ability of adults.

As the Common Rule is revised to provide greater specificity on requirements for informed consent, HHS has an opportunity to clarify and emphasize the relevance of 45 C.F.R. § 46.116(2) to research involving minors and the provisions of Subpart D. In particular, the committee endorses the approach recommended by the Society for Research in Child Development (SRCD) Task Force (Fisher et al., 2013, p. 11):

We recommend that in contexts in which waiver of parental permission is appropriate investigators and IRBs be encouraged to: (1) draw on developmental research to ensure consent language is age-appropriate; (2) include educational procedures within the consent process that enhance minors’ understanding of research and their research rights; (3) evaluate participant rights and protections within the context of existing empirical evidence on children’s developing consent capacity; (4) when appropriate include standardized age-appropriate assessments of prospective participants’ consent capacity; and (5) when the first four steps are insufficient, consider the appointment of an independent participant advocate to ensure children’s informed and voluntary participation (see Gibson et al., 2011; Masty and Fisher, 2008; Vitiello, 2008).

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

In addition, the committee offers the following recommendation for guidance from OHRP on waivers of guardian permission:

Guidance Recommended: OHRP should issue guidance to IRBs to facilitate the use of waiver of guardian permission for research involving adolescents that meet the criteria for minimal risk research. In contexts in which waiver of parental permission is appropriate, OHRP should consider providing guidance to require IRBs and researchers to develop informed consent procedures that ensure children’s informed and voluntary participation.

Informed Consent to Research and Treatment Involving Adults with Impaired Decisional Capacity

The ANRPM proposes that less oversight is needed when “competent adults” are asked to participate in research, with the exception of when “emotionally charged” research is being conducted. The committee is concerned that these terms have implications for the informed consent process and might lead to both underprotection and overprotection of subjects in terms of having a valid and respectful consent process. The term “competent adult” requires further elaboration, as even the term “adult” would require a federal definition. A full deferral to state law notions of what “adult” means may be necessary, as well as to consider state laws regarding emancipated minors. The definition of and risks associated with “emotionally charged” are also unclear and problematic.

The term “competent adults” is not sufficiently defined and has indeterminate implications for what consent process may be deemed appropriate by IRBs. Thus, an ongoing challenge for informed consent is balancing the obligation to respect the rights of those with impaired decisional capacities to be treated as autonomous members of the community with the need to ensure that ill-informed or incompetent decisions will not place their welfare in jeopardy (Appelbaum et al., 1999; Bersoff et al., 1994; Ellis, 1992).

In 1982, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical Research recommended that scientists avoid determining an individual’s incapacity as a decision maker solely on the individual’s status as mentally disabled. The National Bioethics Advisory Commission (1998) extended this recommendation by suggesting that investigators study the consent capacity of people with intellectual disabilities and explore techniques to enhance their decision-making performance. Fisher (2003b) argued that such research is critically important because a diagnosis of mental illness or neurological disorders has often justified allowing other people to make decisions for those with mental impairments, especially when the disabled individual disagrees with the risk-benefit

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

assessment of a research investigator, the cognizant IRB, or the individual’s own physician or family members. Some adults with serious mental disorders have been declared legally incompetent to consent. Removal of a person’s legal status as a consenting adult does not, however, deprive that person of the moral right to be involved in treatment or research participation decisions (Dresser, 1999; Fisher, 1999, 2003b).

For these adults, the committee recommends that guidance be modeled on the American Psychological Association Ethics Code Standard 3.10b, which requires that psychologists obtain the appropriate permission from a legally authorized person and provide an appropriate explanation to the prospective client, patient, or research participant, consider that person’s preferences and best interests, and seek the individual’s assent (American Psychological Association, 2010; Fisher, 2013).

The implementation of ethically appropriate consent procedures is more complex for the many situations in which individuals with impaired decisional capacities, which could be associated with any type of health condition, retain the legal status of a consenting adult, even when their capacity for making informed, rational, and voluntary decisions may be compromised (Carpenter et al., 2000, Dunn et al., 2006). Sole reliance on a diagnostic label to determine a client’s or patient’s capacity to make research participation decisions risks depriving persons with mental disorders of equal opportunities for autonomous choice and risks a failure to attend to ethical issues of justice and access to research (Dunn et al., 2006).

Recommendation 4.4: The committee does not endorse the ANPRM restriction to “competent adults” for the proposed new excused classification. Instead, the committee recommends that OHRP provide guidance for investigators and for the final mechanism of oversight for this category, with the aim of fitting the information required for obtaining consent for the new excused category to the population characteristics and specific research context.

The ANRPM includes proposed reforms for informed consent to long-term use and secondary analysis of research data in general and to use of biospecimens in particular (76 Fed. Reg. 44,519, 44,523). These proposals recognize the rapid and extensive changes occurring in the technologies for data analysis and for archival and retrieval (data mining) of data in large repositories. They have important implications for major data collection activities, such as longitudinal studies and national surveys, as well as for data sharing and secondary analysis of archival data of all kinds.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

As noted by the SRCD Task Force, these new security rules will have significant influence on data generated from longitudinal studies:

Longitudinal studies allow for tests of continuity and change in developmental [and societal] processes and [for research on] the influence of genetic, social, and environmental contexts over time and are essential for assessing the lifelong consequences of medical, educational, clinical, or other interventions [and chronic conditions]. Whether archival data in longitudinal studies or national surveys are identifiable or de-identified, their contribution to society is greatly enhanced by secondary analysis [by investigators over different periods of time].

…

Protection of [participant] privacy rights require[s] that when an investigator wishes to link archival identifiable data with collection of new data [from human subjects], re-consent must occur. We recommend that the consent should be for the new data collection and linking to the archival data set, not for access to the contact information of individuals who participated in the original study. Rather, access to participant contact information should be permitted with a signed letter of agreement between institutions that security and confidentiality rules will be followed. (Fisher et al., 2013, p. 12; adapted by the committee as shown by editorial insertions)

To act on these suggestions, which the committee supports, the revised Common Rule will need to clarify and emphasize that, when investigators’ new research entails linking extant data to the collection of new data from human subjects, the need for informed consent applies only to the new data collection and linking to the archival dataset; the need for informed consent does not extend to access to the contact information of individuals who participated in the original study.

With respect to re-use of biospecimens and other socially sensitive research data, the committee agrees, with one caveat, with the ANPRM that there is no need for re-consent for future use of de-identified information (76 Fed. Reg. 44,519, 44,523):

Future analysis of de-identified data by the original investigator or secondary analysis of de-identified data by other investigators typically poses no informational risk. However, emerging software and biomedical technologies may make original de-identification data security protections obsolete. (Fisher et al., 2013, p. 12)

The committee believes that to ensure responsible future access and use of data “that all investigators who will have access to data in the future will be bound by the best practices in data and confidentiality protections at

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

the time of data collection and [will be bound by] new protections as they emerge” (Fisher et al., 2013, p. 12).

Recommendation 4.5:5 HHS should not introduce a requirement for re-consent for future use of pre-existing, de-identified non-research or research data. When investigators wish to link pre-existing identifiable data to the collection of new data from human subjects, consent should be obtained for the new data collection and linking to the archival identifiable dataset.

Guidance Recommended: OHRP guidance is needed to assist investigators in creating informed consent language for de-identified data storage that makes explicit the requirement that all investigators who will have access to data in the future (1) will be bound by the best practices in data and confidentiality protections at the time of data collection and (2) will also employ new protections as they emerge.

Recommendation 4.5 primarily addresses re-consent for future use of pre-existing de-identified data. Chapter 5, in focusing on information risk and data protection, discusses more broadly data sharing and the various protective mechanisms related to linking de-identified and identifiable data.

5This recommendation was made by the committee in response to an ANPRM-proposed revision to the current regulations, page 44,519. Recommendation 4.5 in the prepublication copy erroneously implied that the recommendation was being made to change current regulations.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Fisher, C.B. (1999). Relational ethics and research with vulnerable populations. Reports on research involving persons with mental disorders that may affect decision-making capacity. Pp. 29-49 in Vol. 2 of Commissioned Papers by the National Bioethics Advisory Commission. Rockville, MD: National Bioethics Advisory Commission.

Fisher, C.B., and Wallace, S.A. (2000). Through the community looking glass: Re-evaluating the ethical and policy implications of research on adolescent risk and psychopathology. Ethics and Behavior, 10(2):99-118.

Fisher, C.B., Kornetsky, S.Z., and Prentice, E.D. (2007). Determining risk in pediatric research with no prospect of direct benefit: Time for a national consensus on the interpretation of federal regulations. American Journal of Bioethics, 7(3):5-10.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Flory, J., and Emanuel, E. (2004). Interventions to improve research participants’ understanding in informed consent for research: A systematic review. Journal of the American Medical Association, 292(13):1593-1601.

National Research Council. (2003). Protecting Participants and Facilitating Social and Behavioral Sciences Research. Panel on Institutional Review Boards, Surveys, and Social Science Research. C.F. Citro, D.R. Ilgen, and C.B. Marrett (Eds.). Committee on National Statistics and Board on Behavioral, Cognitive, and Sensory Sciences. Washington DC: The National Academies Press.

National Research Council. (2013). Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary, pp. 40-43. R. Pool, Rapporteur. Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press.

Nuremberg Military Tribunals. (1949). The Nuremberg Code. Pp. 181-182 in Vol. 2 of Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Washington, DC: U.S. Government Printing Office. Available: http://history.nih.gov/research/downloads/nuremberg.pdf [December 2013].

Oakes, J.M. (2002). Risks and wrongs in social science research: An evaluator’s guide to the IRB. Evaluation Review, 26(5):443-479.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Thorne, B. (1980). You still takin’ notes? Fieldwork and problems of informed consent. Social Problems, 27(3):284-297.

Trice, A.D., and Ogden, E.P. (1986). Informed consent: I. The institutional non-liability clause as a liability in recruiting research subjects. Journal of Social Behavior and Personality, 1(3):391-396.

Trice, T.R. (1987). Informed consent. VII. Biasing of sensitive self-report data by both consent and information. Journal of Social Behavior and Personality, 2:369-374.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Suggested Citation:"4 Informed Consent." National Research Council. 2014. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, DC: The National Academies Press. doi: 10.17226/18614.

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences examines how to update human subjects protections regulations so that they effectively respond to current research contexts and methods. With a specific focus on social and behavioral sciences, this consensus report aims to address the dramatic alterations in the research landscapes that institutional review boards (IRBs) have come to inhabit during the past 40 years. The report aims to balance respect for the individual persons whose consent to participate makes research possible and respect for the social benefits that productive research communities make possible.

The ethics of human subjects research has captured scientific and regulatory attention for half a century. To keep abreast of the universe of changes that factor into the ethical conduct of research today, the Department of Health and Human Services published an Advance Notice of Proposed Rulemaking (ANPRM) in July 2011. Recognizing that widespread technological and societal transformations have occurred in the contexts for and conduct of human research since the passage of the National Research Act of 1974, the ANPRM revisits the regulations mandated by the Act in a correspondingly comprehensive manner. Its proposals aim to modernize the Common Rule and to improve the efficiency of the work conducted under its auspices. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences identifies issues raised in the ANPRM that are critical and feasible for the federal government to address for the protection of participants and for the advancement of the social and behavioral sciences. For each identified issue, this report provides guidance for IRBs on techniques to address it, with specific examples and best practice models to illustrate how the techniques would be applied to different behavioral and social sciences research procedures.

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